Regulatory Focus™ > News Articles > Regulatory Reconnaissance (4 October 2013)

Regulatory Reconnaissance (4 October 2013)

Posted 04 October 2013 | By Alexander Gaffney, RAC

Welcome to Regulatory Reconnaissance, your daily regulatory news and intelligence briefing. Tips? Gripes? Let me know:

In Focus: US

In Focus: International

  • EMA Website Brought Down by Technical Issues, Will be Online Again Late Saturday (EMA)
  • Ranbaxy denies FDA issues will lead to layoffs (Fierce)
  • CFDA Revokes Approval Codes For 25 Drugs (PharmAsia-$)
  • Fecal Transplant, Now in Pill Form (MedPage Today) (CBS) (CBS)

Comments? Suggestions? Email me at

US: Pharmaceuticals/Biotechnology

  • Beleaguered Ben Venue Laboratories to Close After Endemic Quality Problems (Pharmalot) (In-Pharma)
  • FDA approves Pfizer drug for menopause symptoms (Reuters) (Pharma Letter-$) (SCRIP-$) (Pharma Times) (Pfizer) (Fierce)
  • Some companies now tout passing plant inspection (Fierce)
  • FDA warning letters for Indian firms relatively low at 12% (SCRIP-$)
  • Prolonged U.S. Government Shutdown Could Affect Foreign Drug Makers (PharmAsia-$)
  • Bug Juice: Antibiotics' Slow Drip Turns to Flow (BioWorld)
  • Discovery Labs Announces FDA Approval of SURFAXIN (lucinactant) Updated Product Specifications (Press)

US: Medical Devices

  • Device Shutdown Realities At FDA: No New Submission Reviews, And More (Gray Sheet)
  • 21 types of health apps the FDA could regulate but won't (MobiHealthNews)
  • Intuitive Surgical: What's with all the adverse event reports? (Mass Device)
  • Shutdown postpones House hearing on health IT regulation (Modern Healthcare) (Mass Device)
  • J&J Settles Hip Implant Case Set For Trial In Calif. (Law 360-$) (Mass Device) (Fierce)
  • Med-Tech Companies Are Chasing Defects, Not Improving Processes (Medical Devices Summit)
  • Maine Standards Company, LLC Receives FDA Clearance for VALIDATE PSA Calibration Verification / Linearity Test Kit. (Press)

US: Assorted And Government

  • Upcoming IOM Meeting to Discuss Sharing of Clinical Data (IOM)
  • ONC Director Mostashari's next move: Brookings (GHIT) (Brookings)
  • No WTO-Plus Benefits for Countries that Disrespect IP (BIO)
  • House to move bill paying workers hit by the shutdown (The Hill)
  • Small-business office backs off report finding $1.75 trillion cost of regulations (The Hill)
  • More Politics, Less Expertise: What OIRA has Wrought (CPR)
  • Autism Speaks announces Preclinical Autism Consortium for Therapeutics (PACT) (Press)

Upcoming Meetings And Events

  • October 8-9, 2013: Circulatory System Devices Panel of the Medical Devices Advisory Committee Meeting (FDA)
  • 9-10 October 2013: AAMI/FDA Summit on Healthcare Technology in Nonclinical Settings (AAMI)
  • Other Upcoming FDA Advisory Committee Meetings And Topics (FDA)


  • EMA Website Brought Down by Technical Issues, Will be Online Again Late Saturday (EMA)
  • GSK and Genmab announce European submission to regulatory authorities for Arzerra (ofatumumab) as 1st line treatment of Chronic Lymphocytic Leukaemia (CLL) (Press)


  • Ranbaxy denies FDA issues will lead to layoffs (Fierce)
  • CFDA Revokes Approval Codes For 25 Drugs (PharmAsia-$)
  • Sri Lanka Lifts Ban On 116 Drugs Made By Four India Companies (PharmAsia-$)
  • Would an IMI work in Japan? EFPIA thinks so (SCRIP-$)

General Regulatory And Interesting Articles

Regulatory Reconnaissance #171 - 4 October 2013

Regulatory Reconnaissance is our daily intelligence briefing for the regulatory affairs space, bringing you the top regulatory news stories from around the globe. Each weekday morning, we aim to bring you the latest highlights of new approvals, meetings, legal and political developments, regulations and guidance, and the latest trends with the potential to impact regulatory affairs professionals and the industry in which they work.

Did we miss a story? Send us a tweet at @RAPSorg and we'll check it out for inclusion in our next edition of Regulatory Reconnaissance. Want this in your inbox each morning? Sign up for RF Today, our morning intelligence newsletter here.

Need to contact the editor of Regulatory Reconnaissance? Find him on Twitter at @AlecGaffney or send him an email at

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